Using spatial repellents to control Aedes-borne viruses in Sri Lanka
A Cluster Randomized, Placebo Control Trial to Evaluate the Efficacy of a Spatial Repellent (Mosquito ShieldTM) Against Aedes-borne Virus Infection Among Children ≥ 4-16 Years of Age in the Gampaha District, Sri Lanka
NA · University of Notre Dame · NCT05452447
This study is testing whether a new repellent can help reduce infections from mosquito-borne viruses like dengue and Zika in households in Sri Lanka.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 14430 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | University of Notre Dame (other) |
| Locations | 2 sites (Colombo, West and 1 other locations) |
| Trial ID | NCT05452447 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a spatial repellent product in reducing infections from Aedes-borne viruses such as dengue, Zika, and chikungunya in Sri Lanka. It will be conducted as a cluster randomized controlled trial involving households in the Gampaha district, where participants will be monitored for virus infections before and after the intervention. The study will also assess the impact of the spatial repellent on the local Aedes aegypti mosquito population. The ultimate goal is to provide data that could lead to recommendations from the World Health Organization regarding the use of spatial repellents in public health.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 4 to 16 years who reside in the study area and plan to stay for at least 24 months.
Not a fit: Patients outside the age range of 4 to 16 years or those who do not reside in the study area for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective strategies for controlling Aedes-borne virus infections, potentially reducing disease incidence in affected populations.
How similar studies have performed: While the use of spatial repellents is a novel approach in this context, similar studies have shown promise in other regions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
LONGITUDINAL SEROCONVERSION Individual Level Inclusion Criteria: * ≥ 4 - 16 years of age * Plans to stay in residence and/or study area for a minimum of 24 months * Resident of household or frequent visitor (\~20% of day hours in house / month) Exclusion Criteria: * \< 4 and \> 16 years of age * Plans to leave residence and/or study area within next 24 months * Temporary visitor to household (\<20% of day hours in house/ month) FEBRILE SURVEILLANCE Household Level Inclusion Criteria: * Adult head of households agrees to census, health visits and logging resident symptoms when febrile (or in the case of suspected Zika in the absence of fever, presenting with rash, arthralgia, arthritis or non-purulent conjunctivitis). * Individuals spend a minimum of 4hrs per week during the daytime hours or sleep in the house. Exclusion Criteria: * Adult head of households does not agree to census, health visits or logging symptoms of residents. * Households where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). * Sites where no residents spend time during the day (i.e. work 7d a week outside the home). FEBRILE SURVEILLANCE Individual Level Inclusion Criteria: * ≥ 6mo of age. * Fever at the time of presentation or report of feverishness within the previous 24 hours or presenting with a rash, arthralgia, arthritis or non-purulent conjunctivitis (suspicion of ZIKA determined by project physician) * Individual who spends a minimum of 4 hours per week within the household or sleeps in the house. Exclusion Criteria: * \< 6mo of age. * No fever at time of presentation or report of feverishness within the previous 24 hours or not reporting with a rash, arthralgia, arthritis or non-purulent conjunctivitis * Individuals who have spent less than 4 hours in the household during the week prior to illness. ENTOMOLOGICAL MONITORING Household Level Inclusion Criteria: * Adult head of household agrees to surveys. * Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). Exclusion Criteria: * Adult head of household does not agree to surveys. * Properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). SPATIAL REPELLENT INTERVENTION Household Level Inclusion Criteria: * Adult head of households agrees to have intervention applied inside the home and to provide access to team member at 4-week intervals to change products. * Properties where study personnel do not identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile). Exclusion Criteria: * Adult head of household does not agree to Mosquito ShieldTM deployment or study team access. * Properties where study personnel identify a security risk (i.e., site where drugs are sold, residents are always drunk or hostile).
Where this trial is running
Colombo, West and 1 other locations
- Epidemiology Unit, Ministry of Health — Colombo, West, Sri Lanka (RECRUITING)
- Clinical Trials Unit — Ragama, West, Sri Lanka (RECRUITING)
Study contacts
- Principal investigator: Korelege Hasitha Aravinda Tissera, M.D. — Epidemiology Unit, Ministry of Health, Sri Lanka
- Study coordinator: John P Grieco, Ph.D.
- Email: jgrieco@nd.edu
- Phone: 5743617572
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arbovirus Infections, Dengue, Zika, Chikungunya, Spatial Repellent, Transfluthrin, Vector-borne diseases, Mosquito vectors